Pfizer becomes world's 1st Covid vaccine to get full approval in US
The Pfizer-BioNTech Covid-19 vaccine has become the world’s first jab to get full approval, after the United States Food and Drug Administration (FDA) granted it to the shot on Monday, paving way for a new wave of vaccine mandates as the Delta variant batters the country.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the Covid-19 pandemic," acting FDA Commissioner Janet Woodcock said in a statement. “While millions of people have already safely received Covid-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated," she said.
Checks for Full Approval?
The decision to award it approval was based on updated data from the drug’s clinical trial, including a longer duration of follow-up, with safety and effectiveness evaluated among more than 40,000 people.
The US military has previously announced it will mandate the vaccine as soon as it receives full approval, and a slew of private businesses and universities are expected to follow.
Vaccine for Children
The vaccine remains available under emergency use authorization in the US to children aged 12 to 15, but because it has now been fully approved, physicians may prescribe it to children under 12 if they believe it will be beneficial.
India in Talks to Buy 50 Mn Pfizer Doses: Report
India is in talks to buy 50 million doses of Pfizer Inc and German partner BioNTech SE’s COVID-19 vaccine, the Wall Street Journal reported two weeks ago, citing people familiar with the matter. Hours after approving Moderna’s Covid vaccine for restricted emergency use in the country, the Centre had added that it would close the deal with Pfizer Inc, another US Covid-19 vaccine manufacturing firm, very soon. In a media statement Dr VK Paul, Member-Health, Niti Aayog had said, “There are four vaccines now Covaxin, Covishield, SputnikV and Moderna. We will soon close the deal on Pfizer as well".
India, which rolled out one of the world’s largest vaccination drives earlier this year, has been relying heavily on the AstraZeneca vaccine produced by the Serum Institute of India and a home-grown shot produced by Bharat Biotech.
About the Pfizer Vaccine
The Pfizer and BioNTech vaccine uses messenger RNA (mRNA) technology, which relies on synthetic genes that can be generated and manufactured in weeks, and produced at scale more rapidly than conventional vaccines, reports say. Unlike traditional vaccines, which work by training the body to recognise and kill proteins produced by pathogens, mRNA tricks the patient’s immune system to produce viral proteins itself. The proteins are harmless, but sufficient to provoke a robust immune response.
How Efficacious is the Vaccine?
The Pfizer BioNTech vaccine against COVID-19 has an efficacy of 95% against symptomatic SARS-CoV-2 infection, the World Health Organisation says.
Does it Work against New Variants?
According to the WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) all available data on the performance of the vaccine in tests indicated that the vaccine was effective against virus variants.
Is Pfizer Vaccine Safe?
WHO granted the Pfizer BioNTech vaccine EUL on 31 December 2020, after “thoroughly assessed the quality, safety, and efficacy of the vaccine and has recommended its use for persons above the age of 16."
Temperature Storage Requirements
When asked about the vaccine’s ultra-low temperature storage requirements - minus 70 degrees Celsius (-90 F), Pfizer said the company could deliver the shot to vaccination centers using its specially designed, temperature-controlled thermal shippers. It said doses could be stored in ultra-low-temperature freezers for up to six months, in the shippers for up to 30 days by refilling them with dry ice every five days, or in common refrigeration and freezer units for five days.
